Forr IM, IV or SC Use

Rx only

Ephedrine Sulfate Injection, USP is a sterile solutionn of 50 mg ephedrine sulfate in Water for Injection.

Ephedrine ooccurs as fine, white, oodorless crystals or powder and darkens on exposure to light. It is freely soluble in water and sparingly soluble in alcohol.

The chemical name of ephedrine sulfate is (C10H15NO)2•H2SO4 benzenemethanol α-[l - (methylamino) ethyl] - sufate (2:1) (salt). Its molecular weight is 428 .54. The structural formula is:

Ephedrine sulfate is a potent sympathomimetic that stimulates both α and β receptors and has clinical uses related to both actions. Its peripheral actions, which it owes in part to the release of norepinephrine, simulate responses that are obtained when adrenegenic nerves are stimulated. These include an increase in blood pressure, stimulation of heart muscle, constriction of arterioles, relaxation of the smooth muscle of the bronchi and gastrointestinal tract, and dilation of the pupils. In the bladder, relaxation of the detrusor muscle is not prominent, but the tone of the trigone and vesicle sphincter is increased.

Ephedrine sulfate also has a potent effect on the CNS. It stimulates the cerebral cortex and sub-cortical centers, which accounts for its use in narcolepsy.

The cardiovascular responses reported in man include moderate tachycardia, unchanged or augmened stroke volume, enhanced cardiac output, variable alterations in peripheral resistance and usually a rise in blood pressure. The action of ephedrine is more prominent on the heart than on the blood vessels. Ephedrine sulfate increases the flow of coronary, cerebral and muscle blood.

In patients with myasthenia gravis, administration of Ephedrine Sulfate Injection, USP produces a real but modest increase in motor power. The exact mechanism by which ephedrine sulfate affects skeletal muscle contractions is unknown.

Ephedrine Sulfate Injectionn, USP is indicated in the treatment of allergic disorders, such as bronchial asthma The drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotensionn frequently ooccurs. In Stokes-Adams syndromeme with complete heart block, ephedrine has a value similar to that of epinephrine. It is indicated as a central nervous system stimulant in narcolepsy and depressive states. It is also used in myasthenia gravis.

Allergic reactions to ephedrine sulfate are rare. The hypersensitivity, if known, is a specific contraindication. Patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate.

With large doses of ephedrine sulfate most patients will experience nervousness, insomnia, vertigo, headache, tachycardia, palpitation and sweating. Some patients have nausea, vomiting and anorexia. Vesical sphincter spasm may occur and result in difficult and painful urination. Urinary retention may develop in males with prostatism.

Primordial pain and cardiac arrhythmias may occur following administration of Ephedrine Sulfate Injection, USP

Prolonged abuse of Ephedrine Sulfate Injection, USP can lead to symptoms of paranoid schizophrenia. When this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils.

Some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. Temporary cessation of medication and subsequent readministration restores its effectiveness.

SYMPTOMS - The principal manifestation of ephedrine sulfate poisoning is convulsions. In acute poisoning the following signs and symptoms may occur: nausea, vomiting, chills, cyanosis, irritability, nervousness, fever, suicidal behavior, tachycardia, dilated pupils, blurred vision, opisthotonos, spasms, convulsions, pulmonary edema, gasping respirations, coma and respiratory failure. Initially, the patient may have hypertension, followed later by hypotension accompanied by anuria.

TREATMENT - If respirations are shallow or cyanosis is present, artificial respiration should be administered. Vasopressors are contraindicated. In cardiovascular collapse blood pressure should be maintained.

ANTIDOTE - For hypertension, 5 mg phentolamine mesylate diluted in saline may be administered slowly intravenously, or 100 mg may be given orally. Convulsions may be controlled by diazepam or paraldehyde. Cool applications and dexamethasone 1 mg/kg, administered slowly intravenously, may control pyrexia.

Ephedrine Sulfate Injection USP, 50 mg/mL

1 mL vial in packs of 10, NDC 14789-014-01

NEXUS
PHARMACEUTICALS, INC.

10 x 2 mL Vials NDC 14789-014-01

Ephedrine Sulfate
Injection, USP

50 mg/mL

1 mL fill in a 2 mL Vial

Single Dose Vial

Preservative Free

For subcutaneous,
intramuscular or
intravenous use.

Rx only